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Clinical Trials/NCT02239341
NCT02239341
Completed
Not Applicable

Effects of Two In-hospital Antepartum Interventions on Functional Ability and Quality of Life in Early Postpartum Women.

Western University, Canada1 site in 1 country9 target enrollmentOctober 30, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
High-Risk Pregnancy
Sponsor
Western University, Canada
Enrollment
9
Locations
1
Primary Endpoint
Score on the Functional Mobility Assessment Tool
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The current standard of care for pregnant women deemed to be high-risk often involves recommending varying levels of activity-restriction, up to and including hospitalization. High levels of activity-restriction can lead to physical deconditioning of the mother, which can be difficult to recover from after birth. The proposed study will investigate whether a mild muscular conditioning program conducted in bed and given to hospitalized activity-restricted high-risk pregnant women will improve functional ability, cardiovascular deconditioning and overall quality of life in the postpartum period compared to a control group with no in hospital bed-rest exercise program. We hypothesize that women with a in-hospital muscle conditioning program will be better able to perform functional ability tasks and activities of daily living than a control group with no exercise program.

Registry
clinicaltrials.gov
Start Date
October 30, 2014
End Date
December 30, 2017
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Western University, Canada
Responsible Party
Principal Investigator
Principal Investigator

Michelle Mottola

Dr.

University of Western Ontario, Canada

Eligibility Criteria

Inclusion Criteria

  • Hospitalized high-risk pregnant women in hospital for at least 7 days
  • Diagnosed with gestational hypertension
  • Diagnosed with preeclampsia (mild to moderate)
  • Diagnosed with intrauterine growth restriction
  • Single baby
  • Expecting twins
  • Expecting triplets
  • Diagnosed with shortened cervix
  • Diagnosed with threatened pre-term labour (not actively contracting)

Exclusion Criteria

  • Diagnosed with symptomatic placenta previa (bleeding)
  • Diagnosed with severe pre-eclampsia (immediate delivery)
  • Diagnosed with conditions indicating a short term hospital stays of less than 7 days
  • Diagnosed with infections
  • Diagnosed with heart and renal disease
  • Diagnosed with diabetes
  • Diagnosed with metabolic bone disease
  • Diagnosed with hyper-or-hypo-thyroidism
  • Diagnosed with Cushing disease and anemia
  • Women carrying more than 3 babies

Outcomes

Primary Outcomes

Score on the Functional Mobility Assessment Tool

Time Frame: 2 weeks post delivery

The Functional Mobility Assessment Tool was adapted from a senior fitness test, which uses 7 tests to assess muscular strength, aerobic endurance, flexibility and agility (Chair Stand Test, Arm Curl Test, 6-Minute Walk Test, 2-Minute Step Test, Chair Sit-And-Reach Test, Back Scratch Test, and 8-Foot-Up-And-Go Test).

Secondary Outcomes

  • Follow up to Primary outcome Score for Functional Mobility Assessment Tool(2, 6 and 12 months)
  • Quality of life(Baseline (> 28 weeks gestation); 2 weeks post delivery; 2, 6 and 12 months post delivery)

Study Sites (1)

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